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2010-09-27
article
Medical Devices; Reclassification and Codification of the Absorbable Polydioxanone Surgical Suture
Rules and Regulations
D09002ee1bdecc4c7
D09002ee1bdecc571
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
originator
org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing that it has issued an order in the form of a letter to Ethicon, Inc., reclassifying the absorbable polydioxanone surgical (PDS) suture intended for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery, from class III (premarket approval) to class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document entitled ``Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA,'' which is immediately in effect as the special control for the PDS suture, but remains subject to public comment and possible future revision under the agency's good guidance practices. The agency is reclassifying this device into class II because new information supplied by the petitioner indicates that special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device, and there is sufficient information to establish special controls. Accordingly, the order is being codified in the Code of Federal Regulations. Any firm submitting a premarket notification (510(k)) for a new PDS suture will need to address the issues covered in the special control guidance. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness.
67 FR 77675
https://www.govinfo.gov/app/details/FR-2002-12-19/02-31993
02-31993
fr19de02-6
4160-01-S
Docket No. 99P-5589
https://www.govinfo.gov/app/details/FR-2002-12-19/02-31993
https://www.govinfo.gov/content/pkg/FR-2002-12-19/html/02-31993.htm
https://www.govinfo.gov/content/pkg/FR-2002-12-19/pdf/02-31993.pdf
3 p.
77675
77677
67 FR 77675
Code of Federal Regulations
Title 21 Part 878
21 CFR Part 878
Medical Devices; Reclassification and Codification of the Absorbable Polydioxanone Surgical Suture; Federal Register Vol. 67, Issue
RULE
02-31993
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2003-01-21
Docket No. 99P-5589
4160-01-S
02-31993
Final rule.
The Food and Drug Administration (FDA) is announcing that it has issued an order in the form of a letter to Ethicon, Inc., reclassifying the absorbable polydioxanone surgical (PDS) suture intended for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery, from class III (premarket approval) to class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document entitled ``Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA,'' which is immediately in effect as the special control for the PDS suture, but remains subject to public comment and possible future revision under the agency's good guidance practices. The agency is reclassifying this device into class II because new information supplied by the petitioner indicates that special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device, and there is sufficient information to establish special controls. Accordingly, the order is being codified in the Code of Federal Regulations. Any firm submitting a premarket notification (510(k)) for a new PDS suture will need to address the issues covered in the special control guidance. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness.
This rule is effective January 21, 2003. The reclassification was effective September 4, 2001.
Anthony D. Watson, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-3090.
Medical devices:
General and plastic surgery devices
Absorbable polydioxanone surgical suture; reclassification and codification,
http://www.fda.gov/cdrh
http://www.fda.gov/cdrh/guidance.html
Federal Register
Vol. 67, no. 244
Office of the Federal Register, National Archives and Records Administration
2002-12-19
continuing
daily
deposited
born digital
274 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2002-12-19
P0b002ee180a97e20
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr19de02
https://www.govinfo.gov/app/details/FR-2002-12-19
https://www.govinfo.gov/content/pkg/FR-2002-12-19/pdf/FR-2002-12-19.pdf
https://www.govinfo.gov/content/pkg/FR-2002-12-19/xml/FR-2002-12-19.xml
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DGPO
2010-09-27
2023-05-04
FR-2002-12-19
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eng
FR
FR-2002-12-19
67
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